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CTRI Number  CTRI/2025/05/087124 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   TO STUDY THE EFFECT OF RESPIRATORY MUSCLES WEAKNESS ON THE NEED FOR VENTILLATOR AFTER SURGERY IN OLD PATIENTS  
Scientific Title of Study   To study the Proportion of Ultrasonically assessed Diaphragmatic weakness with the need for Postoperative Mechanical Ventilation in Geriatric Patients undergoing Abdominal Surgery under General anaesthesia:An Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jyoti Suthar 
Designation  Postgraduate Student 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Room no 016133 Department of Anaesthesia, All India Institute of Medical Sciences, Virbhadra road,Rishikesh
Room no 016133 Department of Anaesthesia, All India Institute of Medical Sciences, Virbhadra road,Rishikesh
Dehradun
UTTARANCHAL
249203
India 
Phone  08769332691  
Fax    
Email  jyotisuthar.2013@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepak Singla 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Room no 016133 Department of Anaesthesia, All India Institute of Medical Sciences, Virbhadra road,Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepak Singla 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences,Rishikesh 
Address  Room no 016133 Department of Anaesthesia, All India Institute of Medical Sciences, Virbhadra road,Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9068504999  
Fax    
Email  deepak10.4u@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences,Rishikesh 
 
Primary Sponsor  
Name  ALL INDIA INSTITUE OF MEDICAL SCIENCES RISHIKESH 
Address  ALL INDIA INSTITUE OF MEDICAL SCIENCES, VEERBHADRA ROAD, RISHIKESH.249203 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Jyoti Suthar  All India Institute of Medical Sciences,Rishikesh  Room no 016133 Department of Anaesthesia, All India Institute of Medical Sciences, Virbhadra road,Rishikesh
Dehradun
UTTARANCHAL 		 8769332691

jyotisuthar.2013@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  American society of Anaesthesia (ASA) class I to III, undergoing abdominal surgery under general anaesthesia. 
 
ExclusionCriteria 
Details  Refusal to consent for the procedure.
Patients with severely compromised lung function.
Patients with any known cardiac disease.
Patient already on mechanical ventilation.
Patients in shock.
Patient with altered mental status. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the proportion of geriatric patients with diaphragmatic weakness, as assessed by ultrasound, requiring post-operative mechanical ventilation after abdominal surgery under general anaesthesia  immediately after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare the change in the diaphragmatic function from the preoperative period to post-operative period in geriatric patients undergoing abdominal surgery under general anaesthesia  From before to after the surgery 
To study the association of the ultrasound guided diaphragmatic function in the pre and postoperative period with the need for post- operative mechanical ventilation in geriatric patients undergoing abdominal surgery under general anaesthesia  Before the surgery 
To study the association of the ultrasound guided diaphragmatic function in the preoperative and post-operative period with the development of post-operative pulmonary complications in immediate postoperative period as assessed by lung ultrasound  1 hour after the surgery 
To study the association of the ultrasound guided diaphragmatic function in the preoperative period with the preoperative Mini Nutritional Assessment (MNA) score in geriatric patients undergoing abdominal surgery under general anaesthesia  immediately after surgery 
To study the impact of epidural analgesia on change in diaphragmatic function from the preoperative period to post-operative period in geriatric patients undergoing abdominal surgery under general anaesthesia  Immediately after surgery 
To study the association of pre-operative and post-operative diaphragmatic function with post-operative arterial blood gases  1 hour after surgery 
To study the association of pre-operative and post-operative diaphragmatic function with incidence of delayed extubation  1 hour after surgery 
To study the association of pre-operative and post-operative diaphragmatic function with patient outcome i.e. recovery, prolonged hospital stay, prolonged ICU stay, mortality  7 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study protocol will be explained to the patients who will be found eligible for our study, based on inclusion criteria. A written consent will be obtained from those willing to participate in our study. In the preoperative room routine monitors [i.e., pulse oximeter, ECG and non-invasive blood pressure(NIBP)] will be attached and baseline vitals will be obtained. Mini Nutritional Assessment (MNA) score will be calculated in the preoperative period. Diaphragm function will be assessed using ultrasound.

Patients will be taken inside the operation theatre. All the routine monitors i.e., pulse-oximeter, ECG, and NIBP will be attached. An epidural catheter may be inserted based on anaesthetist’s discretion. Patient will be preoxygenated or denitrogenated to increase apnoea time followed by administration of injection (inj.) fentanyl 1-2μcg/kg i.v. Thereafter induction agents i.e., inj. propofol (1-2.5mg/kg) or etomidate (0.2-0.3mg/kg) i.v. will be given. For muscle relaxant inj. vecuronium 0.1 mg/kg i.v. will be used. Patient will be intubated and mechanically ventilated on volume control mode. Ventilatory settings will be as follows: - tidal volume (VT) 6-8ml/kg, respiratory frequency 12-14/min, PEEP 5 cm of H2O so as to maintain an EtCO2 of 30-35. Throughout the surgery the anaesthesia will be maintained using sevoflurane with 40% oxygen and intermittent injection of vecuronium. The Train of four (TOF)-ratio will be measured and dosage of vecuronium will be decided on its basis. The total requirement of muscle relaxant will be noted. Other than routine monitors we will attach bi-spectral index monitor on the forehead of the patient. We will maintain bi-spectral index between the ranges of 40-60.

After the surgery is over, diaphragm assessment (TFdi) will be repeated on both sides.  Lung ultrasound score and ABG will be done for all patients to know the lung condition and need for mechanical ventilation. Patients will be extubated if they are meeting clinical criteria for extubation (i.e., regular respiration, stable vitals, follows commands, hand grip and head lift). Any patient not meeting the criteria for extubation within 1 hour of stopping muscle relaxant will be considered for elective mechanical ventilation as per the discretion of treating anaesthesiologist and surgeon.

All patients will be shifted to either post anaesthesia care unit (PACU) or intensive care unit or high dependency unit (depending upon availability of ventilator). 1 hour post operatively an ultrasonographic assessment of diaphragm, lungs and ABG will be performed to rule out pulmonary complications. Patient outcomes will also be assessed including delayed extubation, recovery, length of hospital stay, prolonged hospital stay, length of ICU stay and mortality for upto a period of 7 days.

 
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